Testing of compounds for inhibition of 50 and 374 wild-type kinase enzymes

INTRODUCTION
PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The Office of Acquisition (OA) at the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) under the Department of Health & Human Services (DHHS), on behalf of the National Center for the Advancement of Transalational Sciences (NCATS) intends to negotiate and award a contract to obtain contractor services for testing of compounds for inhibition of 50 and 374 wild-type kinase enzymes by Reaction Biology Corp. located at 1 Great Valley Parkway, Malvern, PA 19355. The determination by the Government to award a contract without providing for full and open competition is based upon consistency with prior data results and continuity of science and on market research conducted. Specifically, the sources sought type of notice under this solicitation, released on FedBizOpps from January 30, 2019 through February 11, 2019, indicates only one source of supply or service is capable of achieving this Government requirement.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 541380 Testing Laboratories with associated small business size standard of 15,000,000 USD.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2019-01 / 01-22-2019.

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source.

DESCRIPTION OF REQUIREMENT

Project Description
Statement of Work: The Contractor shall perform the following statement of work:

1. Testing results of 10 novel small molecule compounds for inhibition of a set of 50 wild-type kinase enzymes. This testing will inform on kinase inhibitory activity in our compound series and will facilitate further optimization and development of these IRAK4 / FLT3 inhibitor compounds as potential treatments for cancers such as AML and MDS.

2. Testing results of 5 novel small molecule compounds for inhibition of a set of 374 wild-type kinase enzymes. This testing will inform on kinase inhibitory activity in our compound series and will facilitate further optimization and development of these IRAK4 / FLT3 inhibitor compounds as potential treatments for cancers such as AML and MDS.

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the following tasks. Specifically:

1. Perform experiments using the Kinase HotSpot assay platform, or its equal, testing each of 10 small molecule compounds for inhibitory activity against at least 50 wild-type kinase enzymes.

2. Provide a comprehensive report with the results of the 10-dose IC50 singlet titrations of each of the 10 compounds against the 50 wild-type kinases.

3. Perform experiments using the Kinase HotSpot assay platform, or its equal, testing each of 5 small molecule compounds for inhibitory activity against at least 374 wild-type kinase enzymes.

4. Provide a comprehensive report with the results of the 10-dose IC50 singlet titrations of each of the 5 compounds against the 374 wild-type kinases.

Period of Performance
The period of performance will be effective for 6 months from the Effective Date of Contract.

GOVERNMENT RESPONSIBILITIES
Government will have the responsibility to review and approve the final report. Government will have the responsibility to provide sufficient quantities of the lead compound in order to contractor to accomplish the necessary work.

DELIVERY OR DELIVERABLES
Contractor will provide the data analysis and report for the contents of this statement of work. Offerors should indicate an estimated delivery time in full after receipt of an order and any other training or warranty considerations applicable. Inspection and acceptance will be performed at NCATS located at 9800 Medical Center Drive, Rockville, MD 20852.

Purpose and Objectives: The purpose of this requirement is to obtain contractor results of testing of compounds for inhibition of 50 and 374 wild-type kinase enzymes. Prior work at NCATS has produced a series of small molecule IRAK4 / FLT3 kinase dual inhibitors, including NCGC00371481 and its structural analogs. Compounds such as 1481 have shown promising results in cellular and mouse models of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Further optimization of the biochemical, physiochemical and pharmacokinetic properties of these compounds is required, and may eventually produce a clinical candidate that could be used to treat cancers such as MDS and / or AML. Prior analogs in this series were tested against IRAK1, IRAK4, FLT3, and other relevant kinase enzymes using Kinase HotSpot assay technology. The current requirement must also be tested using Kinase HotSpot assay technology to ensure consistency of data.

CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice.

Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) at www.sam.gov.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by the closing date specified in this announcement and must reference the subject announcement number on all correspondences. Responses must be submitted electronically to Mr. Hunter Tjugum at hunter.tjugum@nih.gov. Fax requests are not accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

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